ORTHOCORD SUTURE— 510(k) K040004

Name: FDA 510(k) clearance K040004
Creator: U.S. Food and Drug Administration
Published: 2004-04-13

Substantially Equivalent

Depuy Mitek

FDA 510(k) clearance K040004 for ORTHOCORD SUTURE, Substantially Equivalent on 2004-04-13. Applicant: Depuy Mitek. Device class: 2.

Clearance details

Applicant: Depuy Mitek
Product code: Product code NEW
Device class: Class 2
Regulation: 21 CFR 878.4840
Advisory panel: General, Plastic Surgery
Date received: 2004-01-02
Decision date: 2004-04-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norwood, MA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code NEW

product code NEW

Death: 32
Injury: 2,179
Malfunction: 8,975
Total: 11,186

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.